Name (Synonyms) | Correlation | |
---|---|---|
drug95 | ARCT-021 Dose Regimen 2 Wiki | 1.00 |
drug92 | ARCT-021 Dose 2 Wiki | 1.00 |
drug93 | ARCT-021 Dose 3 Wiki | 1.00 |
drug91 | ARCT-021 Dose 1 Wiki | 1.00 |
drug2122 | Placebo Wiki | 0.05 |
There is one clinical trial.
Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in healthy adult volunteers.
Description: Safety and tolerability of ARCT-021 assessed by determining the incidence, severity and dose-relationship of AEs by dose
Measure: Incidence, severity and dose-relationship of AEs Time: 56 daysDescription: SARS-CoV-2-specific serum neutralizing antibody levels, expressed as GMT
Measure: Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody Time: Up to 56 daysDescription: SARS-CoV-2-specific serum neutralizing antibody levels, expressed as mean titer
Measure: Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels Time: Up to 56 daysDescription: GMFR in titre for SARS-CoV-2-spike protein specific neutralizing antibodies from before vaccination to each subsequent time point
Measure: Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels Time: Up to 56 daysDescription: GMFR in SARS-CoV-2--spike protein-specific binding antibody levels from before vaccination to each subsequent time point
Measure: Increase in SARS-CoV-2--spike protein-specific binding antibody levels Time: Up to 56 daysDescription: GMT for SARS-CoV-2--spike protein-specific binding antibody levels
Measure: Geometric mean SARS-CoV-2--spike protein-specific binding antibody titre Time: Up to 56 daysDescription: Mean titer for SARS-CoV-2--spike protein-specific binding antibody levels
Measure: Mean SARS-CoV-2--spike protein-specific binding antibody titre Time: Up to 56 daysDescription: Proportion of participants that are seronegative before vaccination achieving a titer of greater than or equal to 20 for SARS-CoV-2-specific serum neutralizing antibodies
Measure: SARS-CoV-2-specific serum neutralizing antibody seroconversion rate Time: 56 daysDescription: Proportion of participants that are seropositive before vaccination achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralizing antibody levels
Measure: SARS-CoV-2-specific serum neutralizing antibody seroconversion rate (seropositive baseline) Time: 56 days